Overview

The CMC Operations Manager will drive the CMC programs at CDMOs for development and scale up, cGMP manufacturing, process characterization and qualification for Phase 3 clinical studies and commercial supply. CMC Operations manager will also contribute to regulatory filing and creations of policies and procedures to ensure compliance with US Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs): (21 CFR Parts 210, 211).

Responsibilities

• Adhere to all Standard Operating Procedures, Current Good Manufacturing Principles and Company Policies. Ensure all facilities are in compliance with all applicable state, federal, consignees and CUREVO designated regulations.
• Act as SME and lead technical team at CMDO for late phase recombinant protein drug development for both Drug Substance and Drug Product, including tech transfer, scale up, gap/risk analysis, process characterization/qualification, cGMP manufacturing.
• Provide technical guidance and keep project on time and in compliance with cGMP regulations
• Review and approve controlled documents including batch records, SOPs, protocols and reports related to process development and characterization
• Work closely with QA/QC to identify and evaluate deviations, CAPA and change control.
• Lead and direct the work of our partner organizations and consultants. Build strong communications and relationships with partner organizations and consultants.
• Ensure compliance with both internal Curevo process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
• Collaborate with CDMO for health authority inspection.
• Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
• Actively participate as member of Curevo supporting product and new business development
• Participate for US and International specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements
• Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as otherwise posted or communicated
• Any other duties as assigned.

Job Requirements

• University level science degree and/or equivalent qualification.
• Minimum 5 years experience in process development and CMC operations. Experience with biologics preferred.
• Strong knowledge in protein production and purification for clinical/commercial uses
• Experience in formulation development is desired
• Strong understanding of the regulation requirements from FDA and other regulatory agencies.
• Willing to perform a wide range of duties in a smaller organization on an independent level and as a team player
• Excellent oral and written communication skills; ability to communicate effectively with co-workers and Health Authorities
• Proficiency in MS Office [Excel, Word, PowerPoint, MS Project], JMP statistical software and Adobe Acrobat
• Ability to travel as required by projects (10-25% of time, US and International)
• Ability to work flexible hours for collaboration with international CDMOs/partners

PHYSICAL DEMANDS

• Performing the responsibilities of the job requires regular use of hands to finger, handle, or feel or feel objects, tools, or controls, and to reach with hands and arms. Frequently required to stand, walk, climb, or balance; and to stoop, kneel or crouch. May be required to walk and stand for entire work shifts. Ability to read and type while sitting in front of a computer up to 4 hours at a time. Physically able to adhere to cleanroom gowning requirements of partner organizations. Ability to lift, tub, and pull up to 50 lbs.

WORK ENVIRONMENT

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• This job will on occasion operate within a laboratory or industrial manufacturing setting. This setting will require training and correct use of personal protective equipment (PPE) commensurate with the identified risk of exposure presented. Typically, this entails safety glasses, protective shoes, and disposable gloves.